Staining Effect of Chlorhexidine Clinical Trial
Official title:
Spectrophotometric Evaluation of Chlorhexidine Pigmentations After Periodontal Flap Surgery: a Prospective Randomized Clinical Trial
| Verified date | April 2014 |
| Source | University of Trieste |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
The aim of this clinical trial was to evaluate through a clinical spectrophotometric analysis the staining side effect of a 0.2% CHX mouthwash containing an anti discoloration system (ADS) compared with a 0.12% and a 0.2% CHX alone mouthwash after periodontal surgery. The efficacy of the products and the patient's opinion and acceptance were also assessed.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | September 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Good general health conditions without a medical history of medication that might interfere with periodontal tissues - Good plaque control (FMPS = 25%) and low levels of infection (FMBS = 25%) - Need for periodontal surgery Exclusion Criteria: - Smokers - Allergy to CHX - Lack of written informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale Maggiore | Trieste |
| Lead Sponsor | Collaborator |
|---|---|
| dott. Lorenzo Bevilacqua |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in ?E before and after the use of chlorhexidine | Change in ?E before and after the use of chlorhexidine (?E is a measurement used to indicate how much a color deviates from an accepted standard. Perfect color has a ?E of zero.) | Change from Baseline of ?E after the use of chlorhexidine mouthrinses; change from Baseline of ?E after the use of chlorhexidine mouthrinses at 1 week; change from Baseline of ?E after the use of chlorhexidine mouthrinses at 2 weeks | No |